BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent for Some Indications 🇺🇸 United States

    B. BRAUN MEDICAL INC. TRANSORBENT AND THINSITE BORDER DRESSING

    K Number: K970453 · Decision Apr 11, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    144
    Applicant Total
    149
    Review Days
    79

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    B. BRAUN MEDICAL INC. TRANSORBENT AND THINSITE BORDER DRESSING
    K Number
    K970453
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    B.Braun Medical, Inc.
    Date Received
    January 22, 1997
    Decision Date
    April 11, 1997
    Product Code
    MGQ
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MGQ), ordered by most recent decision date.

    HylaGuard Moisturizing Cream

    FDA 510(k)
    FDA Unclassified ·Unknown

    HYLATOPIC EMOLLIENT FOAM

    FDA 510(k)
    FDA Unclassified ·Unknown

    IMPRUV A.I. CREAM WOUND AND SKIN EMULSION

    FDA 510(k)
    FDA Unclassified ·Unknown

    SILVERSITE OR CALGITROL

    FDA 510(k)
    FDA Unclassified ·Unknown

    SILVERSEAL

    FDA 510(k)
    FDA Unclassified ·Unknown

    TENDERWET ACTIVE

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by B.Braun Medical, Inc.

    K Number Device Name
    K253235 Introcan Safety® Deep Access XL IV Catheter
    K243392 Infusomat® Space Volumetric Infusion Pump Administration Sets
    K240578 VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System
    K241845 Introcan Safety® 2 IV Catheter
    K241385 Omnifix Syringe NRFit
    K231242 Perifix FX Catheter; Contiplex FX Catheter
    K223479 AQUAbase nX
    K220756 Introcan Safety 2 IV Catheter
    K220626 Introcan Safety IV Catheter
    K213778 IV Administration Set
    Search all 149 clearances from B.Braun Medical, Inc. →